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HEPANOSTIKA(TM) HBEAG/ANTI HBE MICROELISA(TM) SYST

Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
ORGANON TEKNIKA CORP.
Trade Name
HEPANOSTIKA(TM) HBEAG/ANTI HBE MICROELISA(TM) SYST
Generic Name
Test, hepatitis b (b core, be antigen, be antibody, b core igm)
Decision Date
5/14/1986
Days to Decision
504 days
Decision Code
APPR
FDA Decision
Approval

HEPANOSTIKA(TM) HBEAG/ANTI HBE MICROELISA(TM) SYST

Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
ORGANON TEKNIKA CORP.
Trade Name
HEPANOSTIKA(TM) HBEAG/ANTI HBE MICROELISA(TM) SYST
Generic Name
Test, hepatitis b (b core, be antigen, be antibody, b core igm)
Decision Date
5/14/1986
Days to Decision
504 days
Decision Code
APPR
FDA Decision
Approval